Kop Petronella, van Wely Madelon, Nap Annemiek, Mol Ben Willem, Bernardus Rob, Brucker Michael De, Janssens Pim, Cohlen Ben, Pieters Jacqueline, Repping Sjoerd, van der Veen Fulco, Mochtar Monique H
Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands
Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
BMJ Open. 2019 Jul 23;9(7):e026065. doi: 10.1136/bmjopen-2018-026065.
At present, studies comparing intrauterine insemination in the natural cycle versus intracervical insemination in the natural cycle in women undergoing artificial insemination with donor sperm are scarce.
We perform a randomised controlled non-inferiority trial among five secondary and tertiary fertility clinics in the Netherlands and one tertiary fertility clinic in Belgium. Women eligible for artificial insemination with donor sperm are included. We perform six cycles of artificial insemination with donor sperm within a time horizon of 8 months comparing intrauterine insemination in the natural cycle with intracervical insemination in the natural cycle. The primary outcome is ongoing pregnancy leading to live birth conceived within eight months after randomisation. Secondary outcomes are clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, pregnancy complications (preterm birth, birth weight <2500 g, pregnancy induced hypertension, (pre-) eclampsia, Hemolysis Elevated Liver enzymes Low Platelets (HELLP)), time to ongoing pregnancy, direct and indirect costs. To demonstrate the non-inferiority of intracervical insemination with a margin of 12%, we need 208 women per arm.
The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on research involving human subjects (47330-018-13). The boards of the participating hospitals approved the study. Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings.
NTR4462.
目前，在接受供精人工授精的女性中，比较自然周期宫内授精与自然周期宫颈内授精的研究较少。
我们在荷兰的五家二级和三级生育诊所以及比利时的一家三级生育诊所进行了一项随机对照非劣效性试验。纳入符合供精人工授精条件的女性。在8个月的时间范围内，我们对自然周期宫内授精与自然周期宫颈内授精进行六轮供精人工授精。主要结局是随机分组后8个月内持续妊娠并活产。次要结局包括临床妊娠率、流产率、多胎妊娠率、妊娠并发症（早产、出生体重<2500g、妊娠高血压、（先兆）子痫、溶血肝酶升高血小板降低综合征（HELLP））、持续妊娠时间、直接和间接成本。为证明宫颈内授精非劣效性且非劣效界值为12%，每组需要208名女性。
该研究已获得学术医疗中心医学伦理委员会以及荷兰涉及人类受试者研究中央委员会（47330 - 018 - 13）的批准。参与医院的董事会批准了该研究。结果将通过同行评审出版物以及在国际科学会议上的报告进行传播。
NTR4462。
